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Sites handled from around the globe
A variety of global and domestic studies involving a range of topics from diabetes in babies and children to cystic fibrosis to very rare diseases might one day owe at least some of their success to a single data coordinating center in Tampa, FL.
A state-of-the-art electronic data coordinating center at the University of South Florida in Tampa handles four major research projects, which enroll participants from across the world.
The data coordinating center handles clinical trial information for the Rare Diseases Clinical Research Network (RDCRN), The Environmental Determinants of Diabetes in the Young (TEDDY) study, the TRIGR study which is looking at the incidence of type 1 diabetes among infants raised exclusively on breastfeeding versus two specialized formulas, and the Therapeutics Development Network of the Cystic Fibrosis Foundation.
The TRIGR trial has clinical trial sites in 15 countries, including the United States, says Jeffrey P. Krischer, PhD, a professor at the University of South Florida, College of Medicine.
"All of the data collection systems for this trial are Web-based, and we've implemented most of our data collection forms in 11 different languages," Krischer says. "This accommodates local language requirements and gives us an international system for reporting and reviewing any adverse events that should occur during the trial."
Here are some examples of benefits of having a data coordinating center handle a multi-site trial's information:
• Report adverse events more efficiently: "We have an international system for reporting and reviewing any adverse events that should occur during the trial," Krischer says. "The adverse event system is all technology-based, which allows an investigator to submit notification of an AE or a follow-up of an AE to have that item reviewed internationally by our own safety monitoring group."
The safety monitoring group looks at the severity of the AE and the number of people experiencing AEs, versus the number of people enrolled in the study, he says.
"This information allows them to review AEs to initiate discussion and request follow-up information for reporting to the data safety monitoring board (DSMB)," Krischer says. "We developed this novel system electronically."
Safety monitoring through the electronic system is effective and timely, he notes.
For example, there was one patient death on the study, but not related to the study, and it was reported in Australia first and then reviewed by medical monitors located 1,000 miles away in less than 24 hours, Krischer says.
"We could satisfy ourselves there were no issues that required additional follow-up or changes in our study protocol," he adds.
• Improve communication across borders: "When you're trying to deal with a study that's wide geographically, you have to deal with communication issues and facilitating the flow of information," Krischer says.
"We use an electronic system to manage the data effectively," he says. "This way we can have an event occur in Australia and have it reviewed by somebody in Europe and provide whatever feedback is necessary and required."
Information is monitored in the Tampa data coordinating center and reviewed in a timely manner.
"We serve as a mediator to obtain any additional information," Krischer says. "It works well, and we can monitor for any reportable AEs, tabulate any AEs, and produce the information in pre-formatted tables so each site can use these when they have to submit new information to the IRB."
The format also works well for DSMBs, he notes.
"The DSMB meets periodically, and we have a high degree of confidence that they can see these reports as necessary," Krischer says. "We set them up so if they need to be notified, they can be notified immediately."
Also, there's a secure part of the Web site where DSMB members can review reports and ongoing tabulated figures, and this is updated electronically, Krischer explains.
Communication is made easier for other types of reporting, as well.
For the Rare Diseases Network, the system now is extended to having information reported to sponsors, and direct reporting to regulatory bodies also could be automatically handled, Krischer says.
• Maintain flexibility for different study designs: "Other people are interested in the same idea, but our system includes not only reporting, but managing the whole review process, which we think is important," Krischer says. "That's what we pride ourselves for doing."
The data coordinating center has to be flexible to handle the many different study designs and reporting requirements, he notes.
"We can report to the pharmaceutical company or a National Institutes of Health (NIH) institute," Krischer says. "Every study can be customized, and they can be notified when they occur."
For each report, it is customized into a format that fits the institution's format, and it's a seamless process, he says.
• Monitor study progress: The data coordinating center staff designed all of the studies with embedded design operating characteristics, including a trial's sample size and timeline for accruing participants, Krischer says.
"So we routinely monitor accrual on a study relative to its timeline, and we monitor outcomes relative to what's expected," he adds. "So if we're expected to accrue a certain number of patients over five years, then we project the accrual over the sites involved and determine what the accrual should be per site to meet the study's goals."
As studies enroll participants, the accrual is monitored in real time, and the center produces monthly reports about accrual, Krischer says.
This same information can be used to calculate expected outcomes given a particular accrual rate, and the actual outcomes can be compared with what is expected, he adds.
For example, if accrual is lagging behind what's expected, then the center staff can work with the research group and network of sites to see whether the accrual period should be extended, or whether it would be possible to meet the goals of the study, Krischer says.
"By the same token, when we look at expected outcomes, we have to recognize that trials are sometimes designed to have a certain number of outcomes, and it's key to have adequate power to decide whether the study question can be answered," Krischer explains.
This is why it's important to monitor a study's accrual, as well as its adverse events, he adds.
"We make sure a study is progressing, so over a fixed amount of time there will be accrual of a sufficient number of patients," Krischer says.
"This makes you have more confident that the studies you conduct will be successful, and that's our intent," he adds.
The electronic data coordinating systems the center has built are both generalizable and scalable, meaning the center can handle a large number of different types of studies, Krischer notes.
"The overall goal is the successful conduct of research," he says.